Oral amoxicillin versus benzyl penicillin for severe pneumonia among Kenyan children: A pragmatic randomized controlled noninferiority trial

Clinical Infectious Diseases

Volumn 60, Issue 8, 2015, Pages 1216-1224

  Agweyu, Ambrose ^a   Gathara, David ^a   Oliwa, Jacquie ^a   Muinga, Naomi ^a   Edwards, Tansy ^b   Allen, Elizabeth ^c   Maleche Obimbo, Elizabeth ^d   English, Mike ^a,e  

^a KEMRI WELLCOME TRUST RESEARCH PROGRAMME   (Kenya)

^b MEDICAL RESEARCH COUNCIL   (United Kingdom)

^c LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^d UNIVERSITY OF NAIROBI   (Kenya)

^e UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

amoxicillin; childhood pneumonia; sub Saharan Africa; treatment failure; World Health Organization

Indexed keywords

AMOXICILLIN; PENICILLIN G; ANTIINFECTIVE AGENT;

ANEMIA; ARTICLE; CHILD; COMORBIDITY; CONTROLLED STUDY; DETERIORATION; DIARRHEA; DISEASE SEVERITY; DRUG TREATMENT FAILURE; FEMALE; FOLLOW UP; HUMAN; INFANT; INTENTION TO TREAT ANALYSIS; KENYAN; MAJOR CLINICAL STUDY; MALARIA; MALE; MALNUTRITION; MORTALITY; MULTICENTER STUDY; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; WHEEZING; CLINICAL TRIAL; COMPARATIVE STUDY; KENYA; PNEUMONIA, BACTERIAL; PRESCHOOL CHILD; TREATMENT FAILURE;

AMOXICILLIN; ANTI-BACTERIAL AGENTS; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; KENYA; MALE; PENICILLIN G; PNEUMONIA, BACTERIAL; TREATMENT FAILURE;

EID: 84926632952     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciu1166     Document Type: Article

References (23)

1. Walker CL, Rudan I, Liu L, et al. Global burden of childhood pneumonia and diarrhoea. Lancet 2013; 381:1405-16.
2. Niessen LW, ten Hove A, Hilderink H, WeberM, Mulholland K, EzzatiM. Comparative impact assessment of child pneumonia interventions. Bull World Health Organ 2009; 87:472-80.
3. Government of Kenya. Basic paediatric protocols. Nairobi: Ministry of Health, 2013.
4. World Health Organization. Department of Child and Adolescent Health and Development. Pocket book of hospital care for children: guidelines for the management of common illnesses with limited resources. Geneva, Switzerland: WHO, 2013.
5. Hazir T, Fox LM, Nisar YB, et al. Ambulatory short-course high-dose oral amoxicillin for treatment of severe pneumonia in children: a randomised equivalency trial. Lancet 2008; 371:49-56.
6. Addo-Yobo E, Chisaka N, Hassan M, et al. Oral amoxicillin versus injectable penicillin for severe pneumonia in children aged 3 to 59 months: a randomised multicentre equivalency study. Lancet 2004; 364:1141-8.
7. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336:924-6.
8. World Health Organization. Recommendations for management of common childhood conditions: evidence for technical update of pocket book recommendations: newborn conditions, dysentery, pneumonia, oxygen use and delivery, common causes of fever, severe acute malnutrition and supportive care. Geneva, Switzerland: WHO, 2012.
9. Nair H, Simoes EA, Rudan I, et al. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet 2013; 381:1380-90.
10. Agweyu A, Opiyo N, English M. Experience developing national evidence based clinical guidelines for childhood pneumonia in a lowincome setting-making the GRADE?. BMC Pediatr 2012; 12:1.
11. Peto R, PikeMC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976; 34:585-612.
12. Awasthi S, Agarwal G, Singh JV, et al. Effectiveness of 3-day amoxycillin vs. 5-day co-Trimoxazole in the treatment of non-severe pneumonia in children aged 2-59 months of age: a multi-centric open labeled trial. J Trop Pediatr 2008; 54:382-9.
13. Pakistan Multicentre Amoxycillin Short Course Therapy pneumonia study group. Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment of childhood pneumonia: a multicentre double-blind trial. Lancet 2002; 360:835-41.
14. Agarwal G, Awasthi S, Kabra SK, et al. Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial. BMJ 2004; 328:791.
15. Catchup Study Group. Clinical efficacy of co-Trimoxazole versus amoxicillin twice daily for treatment of pneumonia: a randomised controlled clinical trial in Pakistan. Arch Dis in Child 2002; 86:113-8.
16. Berkley JA, Maitland K, Mwangi I, et al. Use of clinical syndromes to target antibiotic prescribing in seriously ill children in malaria endemic area: observational study. BMJ 2005; 330:995.
17. Ayieko P, Ntoburi S, Wagai J, et al. A multifaceted intervention to implement guidelines and improve admission paediatric care in Kenyan district hospitals: a cluster randomised trial. PLoS Med 2011; 8: e1001018.
18. Addo-Yobo E, Anh DD, El-Sayed HF, et al. Outpatient treatment of children with severe pneumonia with oral amoxicillin in four countries: the MASS study. Trop Med Int Health 2011; 16:995-1006.
19. English M, Gathara D, Mwinga S, et al. Adoption of recommended practices and basic technologies in a low-income setting. Arch Dis Child 2014; 99:452-6.
20. Reed C, Madhi SA, Klugman KP, et al. Development of the Respiratory Index of Severity in Children (RISC) score among young children with respiratory infections in South Africa. PLoS One 2012; 7: e27793.
21. Rothwell PM. External validity of randomised controlled trials: 'to whom do the results of this trial apply?' Lancet 2005; 365: 82-93.
22. Bari A, Sadruddin S, Khan A, et al. Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial. Lancet 2011; 378:1796-803.
23. Atkinson M, Lakhanpaul M, Smyth A, et al. Comparison of oral amoxicillin and intravenous benzyl penicillin for community acquired pneumonia in children (PIVOT trial): a multicentre pragmatic randomised controlled equivalence trial. Thorax 2007; 62:1102-6.